This invention relates generally to medical devices, and more particularly to devices and methods of use for removing an introducer sheath or other elongated tubular member which has been used to place a cardiac pacemaker (pacing) lead or other elongated intravascular instrument at a desired position within the body of a patient and without disturbing that pacing lead or instrument.
In U.S. Pat. No. 4,687,469 (Osypka) there is disclosed a hand-held slitter device for slitting a splittable introducer sheath used to place a cardiac pacing lead to permit the sheath to be removed without having to withdraw it over an end of a pacemaker lead.
In U.S. Pat. No. 5,713,867 (Morris) there is disclosed an introducer system including a kink-resistant sheath for use in placing a cardiac pacing lead. The sheath is constructed so that it can be readily split longitudinally utilizing a hand-held slitter device to permit the sheath to be removed without having to withdraw it over the proximal end of the pacemaker lead.
In current electrophysiology practice, the physician typically uses both hands to grasp and peel or split an introducer sheath to remove it from a cardiac pacing lead that has been positioned through the sheath to a desired location within the patient""s body. A second person is sometimes used to hold the pacing lead in the desired position while the sheath is removed to ensure that the pacing lead is not displaced or moved. Alternatively, and more commonly, the physician holds the pacing lead with one hand, and withdraws the introducer sheath a short distance with the other hand. Then the physician grasps each half of the split peel-away hub and peels the sheath apart a short distance further. Once this is accomplished the physician again holds the pacing lead a little further up, and withdraws the introducer sheath a short distance further. This incremental series of motions is repeated several times until the introducer sheath is completely removed from the patient and the pacing lead, to minimize any displacement of the pacing lead.
As should be appreciated by those skilled in the art a primary concern of the physician during this repetitive procedure centers around the numerous manipulations necessary to remove the introducer from the pacing lead, and the significant potential for moving the freshly placed tip of the pacing lead, since some pacing leads exhibit a tendency to move out of position if the lead is pulled or otherwise disturbed.
Thus, need presently exists for a device for stabilizing or holding a cardiac pacing lead or any other elongated intravascular instrument at a desired position within a patient""s body to facilitate the removal of a tearable or otherwise splittable introducer, without disturbing that pacing lead or other elongated intravascular instrument.
In accordance with one aspect of this invention a holding device is provided for use with an elongated flexible member, e.g., a cardiac pacing lead, and a tubular introducer member, e.g., a peelable or tearable introducer sheath or catheter. The tubular introducer member is arranged to be extended into the body of a living being, with the elongated flexible member arranged to extend through the tubular introducer member into the being""s body for location at a desired position. The tubular introducer member is arranged to be withdrawn proximally from the being""s body after the elongated flexible member is in the desired position. The elongated flexible member has a proximal portion that deters the tubular introducer member from being withdrawn out of the being""s body while the elongated flexible member is in place extending through the tubular introducer member.
The holding device comprises a first portion, e.g., a xe2x80x9cgripperxe2x80x9d portion, and a second portion, e.g., a xe2x80x9csplitterxe2x80x9d portion. The first portion of the holding device is operable, e.g., includes at least one contoured engagement surface or jaw, to grasp a portion of the periphery of the elongated flexible member to hold the elongated flexible member at the desired position within the being""s body. The second portion of the holding device is arranged to cause the tubular introducer member to separate longitudinally, e.g., the second portion includes a sharp edge portion for engaging the tubular introducer member to split the tubular introducer member longitudinally, when the tubular introducer member is withdrawn, e.g., pulled proximally with respect to the holding device, as the holding device is held in place gripping the elongated flexible member. Once it is separated, e.g., split, longitudinally, the tubular introducer member can be removed from the elongated flexible member leaving the elongated flexible member at the desired position within the being""s body.
In accordance with another aspect of this invention a method is provided for holding an elongated flexible member, e.g., a cardiac pacing lead, in place extending into the body of a living being to a desired position through a tubular introducer member extending into the being""s body, and for enabling the tubular introducer member to be withdrawn from the being""s body when the elongated flexible member is held in place. The tubular introducer member includes a proximal portion. The elongated flexible member has a proximal portion that deters the tubular introducer member from being withdrawn out of the being""s body while the elongated flexible member is in place extending through it.
The method comprises the steps of providing a holding device having a first portion and a second portion, longitudinally separating the proximal portion of the tubular introducer member to expose a portion of the periphery of the elongated flexible member, utilizing the first portion of the holding device to grip the exposed portion of the periphery of the elongated flexible member to hold the elongated flexible member at a desired position within the being""s body, and withdrawing the tubular introducer member in the proximal direction to bring portions of it into engagement with the second portion of the holding device. This action causes the tubular introducer member to separate longitudinally along its entire length so that it can be removed from the being""s body, leaving the elongated flexible member at the desired position within the being""s body.